Alendronate

Product NDC
69543-130
11-digit product format
695430130
Labeler code
69543
Product ID
69543-130_91a3617f-bde7-4868-9334-f6f61e8440d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALENDRONATE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Virtus Pharmaceuticals
Application
ANDA090258
Marketing category
ANDA
Marketing start
2016-05-12
Marketing end
2024-03-30
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-130-04EA - Each69543-1308caba985-5180-40ad-9be1-79e39603da6b12015-11-12
69543-130-12EA - Each69543-1305c09097e-8eb2-4330-8a40-7a7e472de14b12015-11-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN9955ffad-e774-4e2c-a42b-77118ba7bd213
904396alendronic acid 35 MG Oral TabletSCD9955ffad-e774-4e2c-a42b-77118ba7bd213
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY9955ffad-e774-4e2c-a42b-77118ba7bd213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-130-04695430130041 BLISTER PACK in 1 CARTON (69543-130-04) > 4 TABLET in 1 BLISTER PACK1 blister pack2016-05-192024-03-30NoNoCurrent
69543-130-12695430130123 BLISTER PACK in 1 CARTON (69543-130-12) > 4 TABLET in 1 BLISTER PACK3 blister pack2016-05-120000-00-00NoNoCurrent